Plenum® Osshp in Maxillary Sinus Elevation Surgery

November 14, 2023 updated by: M3 Health

Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum® Osshp in Maxillary Sinus Elevation Surgery

The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of Plenum® Osshp with i-PRF (i-PR - injectable platelet-rich fibrin). For this, forty (40) participants will be recruited, divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery, with the aid of a volumetric tomography machine for dentofacial images. The values obtained at T2 will be subtracted from those obtained from T1 to obtain the volumetric stability value. After six months of repair, biopsies will be performed using a trephine drill, followed by the installation of implants and healers. Through microcomputed tomography analysis, the parameters of bone volume fraction (BV/TV), total porosity (Po.Tot), trabecular thickness (Tb.Th), number of trabeculae (Tb.N) and separation of trabeculae (Tb.Sp) will be evaluated. Histomorphometric analysis will be performed to obtain the areas of bone neoformation, connective tissue and remaining biomaterial that will be calculated for each area of the sample (cervical, intermediate, and apical) and later summed, obtaining the total representative area of the sample. Through immunohistochemical analysis, specific primary antibodies to Runx2, VEGF, Osteocalcin (OC) and Tartrate-Resistant Acid Phosphatase (TRAP) will be identified. The occurrence of adverse events will be collected through the analysis of pain, infection, and edema. The quantitative results of the histomorphometric, microtomographic, and volumetric stability analysis will be tabulated and submitted to the ANOVA test, and if they present a statistically significant difference, it will be followed by the Tukey test (post hoc). A significance level of p<0.05 will be adopted for all tests.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Sao Paulo
      • Araraquara, Sao Paulo, Brazil, 14800900
        • Recruiting
        • Universidade Estadual Paulista - UNESP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with alveolar ridge atrophy, with bone remnant less than 5 mm in height, with adequate bone volume in the ramus and/or symphysis region;
  • Over 18 years old;
  • And that they have signed the informed consent form.

Exclusion Criteria:

  • Smokers;
  • Patients with uncontrolled systemic diseases;
  • Patients with blood dyscrasias;
  • Patients with sinus pathologies;
  • Patients who take or have used medications that interfere with bone turnover;
  • Patients irradiated in the head and neck region;
  • Pregnant patients;
  • Patients with untreated periodontal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Autogenous bone graft
The maxillary sinus will treated with autogenous bone graft.
Procedure: Group 1: Autogenous bone graft
The maxillary sinus will be grafted with the autogenous bone graft.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift
Experimental: Group 2: Plenum® Osshp
The maxillary sinus will treated with Plenum® Osshp.
Procedure: Group 2: Plenum® Osshp
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift
Experimental: Group 3: Plenum® Osshp; + i-PRF
The maxillary sinus will treated with Plenum® Osshp associated with i-PRF (i-PR - injectable platelet-rich fibrin).
Procedure: Group 3: Plenum® Osshp; + i-PRF
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with i-PRF.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift
Experimental: Group 4: Plenum® Osshp + autogenous bone graft
The maxillary sinus will treated with Plenum® Osshp associated with autogenous bone graft.
Procedure: Group 4: Plenum® Osshp + autogenous bone graft
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with autogenous bone graft.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of the maintenance of volume in the maxillary sinus region.
Time Frame: Fifteen days (T1) and six months (T2) from postoperative.
Computed tomography scans were performed and compared after graft surgery (T1) and after 6 months of repair (T2). The maintenance of the volume will be defined by the difference in the area of T2-T1.
Fifteen days (T1) and six months (T2) from postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.
Time Frame: Six months from postoperative.
Microcomputed tomography analysis using the following variables: Bone volume fraction, total porosity, trabecular thickness, number of trabeculae and separation of trabeculae.
Six months from postoperative.
Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.
Time Frame: Six months from postoperative.
Histomorphometric analysis of the experimental groups.
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for Runx2.
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for VEGF.
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for Osteocalcin (OC)
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for Tartrate-Resistant Acid Phosphatase (TRAP).
Six months from postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M3 Health

Collaborators

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Study Director: Sybele Specian, PhD, Plenum (M3 Health)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Plenum Oss 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Surgical Procedures

Clinical Trials on Group 1: Autogenous bone graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe